A Multicentre, Prospective, Observational Clinical Study Evaluating the Outcomes of a Cementless Metaphyseal Short Stem After Hip Arthroplasty

Limacorporate S.p.a1 site in 1 country80 target enrollmentSeptember 2013

ConditionsTotal Hip Arthroplasty

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Total Hip Arthroplasty
Sponsor: Limacorporate S.p.a
Enrollment: 80
Locations: 1
Primary Endpoint: UCLA activity score
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Post-marketing clinical study,international, multi-centre, prospective, observational. The investigation will be carried out in 2 sites in Europe for a maximum total number of 160 patients.The aim of this study is to assess clinical, radiographic and subjective outcomes after hip arthroplasty with a cementless metaphyseal MINIMA short stem, define the survivorship of the implant and identify possible risk factors that may lead to failure.

Registry

clinicaltrials.gov

Start Date

September 2013

End Date

February 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Limacorporate S.p.a

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Both genders
•Age ≥ 18 years old
•Life expectancy over 5 years
•Ambulatory patients
•Painful primary coxarthrosis
•Painful secondary coxarthrosis
•Avascular necrosis
•Willingness to comply with rehabilitation and study evaluation and ability to return for follow-up visits
•Signed study-specific Informed Consent Form

Exclusion Criteria

•Body mass index over 28 kg/m2 for the modular version
•Requiring revision of previous standard femoral stem
•Symptomatic OA of the knees, spine, ankles or contralateral hip, if it can interfere with the evaluation of the target hip according to the Investigator
•Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an HHS\< 60 points
•Significant proven or suspicious infection of the target hip
•Any serious infectious disease before the study according to the Investigator
•Muscular insufficiency that may compromise functional recovery
•Proven osteopenia and osteoporosis severe enough to compromise the stem support according to the Investigator
•Known or suspicious hypersensitivity to the metal of the implant
•Recurrent medical history of immune-mediated reactions or other systemic immune disorders